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plexrec

04/05/19 6:32 PM

#188411 RE: Jonjones325 #188407

Jonjones---thanks for your report--all systems "GO" !!!!!!!!

Jonjones325

04/05/19 6:34 PM

#188413 RE: Jonjones325 #188407

A little more. He said he thinks that 2-73 would work on Schizophrenia but we don't have money for all these trials so we're piggy backing on ERP to be involved but not invest in a trial.

He said if we had the money, we'd be running a ton of trials.

He also said that we might get our own sales team for Rett for since it's a manageable sized market but due to the massive size of Alz and PDD, we'll need a partner.

If he didn't expect success, he wouldn't be talking about commercialization and wouldn't waste good money on stockpiling a supply for it. IMO of course.

Bourbon_on_my_cornflakes

04/05/19 8:12 PM

#188443 RE: Jonjones325 #188407

Great summary Jonjones. You even got the side quotes, as if you were there.

your brother came loaded for bear, asked a lot of good questions.

Only thing I might interpret differently:

Someone asked if there would be another trial after the phase 2B/3. Missling stated that this one is our phase 3 not a pre-phase 3. I’m taking that to assume that no other trial would be needed afterwards.

I took this a bit differently. Dr. M said a 2B/3 is a p2 trial structured to the parameters of a p3 trial. So yes in terms of quality it is exactly what they would run as a p3, including large sample of 450. As whether govt thinks that way, Missling would like them to take it as such, and got directly to P4 with accelerated approval, but he was very conservative in setting expectations by saying FDA could require p3 because so many people would take this drug, huge market.

NO discussion of 371 for those who asked.

ClosetInvestor

04/06/19 9:00 AM

#188496 RE: Jonjones325 #188407

Thanks for posting.

Jimmy6969

04/06/19 1:09 PM

#188571 RE: Jonjones325 #188407

Thank you Jonjon. Seems to shed light on our future prosperity.